Device product
ConvaTec Natura Stomahesive Post-Operative / Surgical Ostomy System, REF 416938, 1 3/4 in. 45mm, Sterile.
Z-1276-2024
Product summary
- Firm
- ConvaTec, Inc
- Event
- Event 93896
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1,715 units
- Official record key
device-enforcement:Z-1276-2024
Official wording
Reason: The kit contains a flange that has a 45mm coupling ring, however, the pouch within the kit is for a 57mm coupling ring.
Code information: Lot #2C02496, UDI-DI #00768455116096.
Distribution pattern: Distribution was made to AK, CA, FL, IL, IN, MI, NE, NJ, NY, OH, PA, and TX. There was government distribution but no military distribution. Foreign distribution was made to Canada.
Derived failure modes
-
Unknown
The kit contains a flange that has a 45mm coupling ring, however, the pouch within the kit is for a 57mm coupling ring.